FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 2962818
·
Received February 14, 2013
Report
- Report Number
- 2938836-2013-00110
- Event Type
- Malfunction
- Date Received
- February 14, 2013
- Date of Event
- December 18, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FRACTURE COULD NOT BE CONFIRMED. EXTERNAL INSULATION ABRASION WAS FOUND AT 5.8-6.0CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. EXTERNAL INSULATION ABRASION WAS FOUND AT 8.2-8.6CM FROM THE TIP ELECTRODE, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR HEART STRUCTURE. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT LEAD NOISE AND FRACTURE WERE NOTED. HIGH SHOCK IMPEDANCE WAS ALSO OBSERVED. LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64961 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7002/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |